CClinicalTrials.gg
Status unknownNCT03273959Updated Sep 6, 2017

Program Of Exercises During The Hospitalization Of Children And Adolescents With Cystic Fibrosis

An interventional study of Exercise protocol in Cystic Fibrosis, Cystic Fibrosis in Children and Cystic Fibrosis Pulmonary Exacerbation, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

The objective of this study was to evaluate the effect of a physical exercise program on the functional capacity of children and adolescents with cystic fibrosis hospitalized at the Hospital de Clínicas of Porto Alegre (HCPA) through a six-minute walk test using the distance traveled In six minutes.

In the first 48 hours of hospital stay, the following evaluations will be performed: Six-minute walk test, physical and health fitness test, spirometry and data collection. Patients will be randomized to either control group or intervention group. The control group will receive the conventional treatment offered by hospital care, the intervention group will receive this same treatment plus an exercise protocol. After 14 days they will be reevaluated with the same tests applied at the beginning of hospitalization.

Read the detailed description

The objective of the study is to evaluate the effect of a protocol of physical exercises on the functional capacity of children and adolescents with cystic fibrosis, hospitalized, in the stage of exacerbation of the disease.

In the first 48 hours of hospitalization patients and their caregivers will be invited to participate in the study. We will start with the following evaluations: Six-minute walk test, spirometry, physical fitness and health test (includes: walking, abdominal, flexibility and abdominal circumference), clinical score of shwachman kulczycki and Collected data from medical records.

After the initial evaluation the patient will be randomized to control group or intervention group. The control group will receive the conventional physiotherapy by the assistance team and the recreation service by the physical education. The intervention group will receive the same assistance plus the intervention with the exercise protocol five times a week supervised by a health professional. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.

At hospital discharge both groups will repeat the initial tests. The hypothesis is that the intervention group showed an improvement in functional capacity compared to the control group.

02

Conditions studied

  • Cystic Fibrosis
  • Cystic Fibrosis in Children
  • Cystic Fibrosis Pulmonary Exacerbation
  • Cystic Fibrosis With Exacerbation

Keywords

  • Physiotherapy
  • Physical Therapy
  • Exercise
  • Hospitalization
  • Pediatric
  • Adolescents
03

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • They will be included in the study of patients from 6 to 18 years old, regularly followed by the Pediatric Pulmonology team of the HCPA, with diagnosis of cystic fibrosis according to the consensus criteria admitted to hospital admission due to exacerbation of the disease.
  • Hospital admission is defined as a stay of 24 hours or more in any HCPA unit.
  • An exacerbation of lung disease is defined as the presence of one or more of the following: Change in sputum volume and color, new or enlarged hemoptysis, increased cough, increased dyspnoea, malaise, fatigue, lethargy, fever, anorexia or Loss of weight, headache or pain in the sinuses, alteration of the pulmonary auscultation, non-FEV1 decrease of more than 10%, radiological, eradication of new bacteria.

Exclusion criteria

Exclusion Criteria:

  • Patients with cardiac, orthopedic or trauma complications that make it impossible to perform the proposed exercises;
  • Patients with hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.
  • Pregnant women
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Group control

    Patients randomized to the control group will receive routine physiotherapeutic follow-up, performed by the physiotherapist of the hospital during the hospitalization period. Supervision includes inhalation therapy and respiratory physiotherapy. Respiratory exercises and thoracic maneuvers for bronchial hygiene will be performed, according to what the patient is accustomed to perform. Other techniques besides these can be added at the discretion of the physiotherapist according to the needs of the patient. In pediatric hospitalization patients also receive care from physical educators who associate recreational and recreational activities with the treatment.

  • Experimental
    Intervention group

    Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive a program of physical exercises, illustrated in the form of a booklet and guided by a health professional. The patient is instructed to perform physical exercises five times a week until a hospital discharge. The participant will receive with a booklet a diary to write down the days in which to carry out the proposed exercises, in case of fault he will write down the reason for not performing. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.

    Other: Exercise protocol

Interventions

  • OtherExercise protocol

    Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.

05

What researchers measure

Primary outcomes

  1. Functional capacity

    Evaluate the distance covered by the six-minute walk test

    Time frame: 14 days

Secondary outcomes

  1. Pulmonary functional capacity

    Spirometry

    Time frame: 14 days

  2. Physical fitness and health

    Generate a score.

    Time frame: 14 days

  3. Clinical score Shwachman-Kulczycki

    Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.

    Time frame: 14 days

  4. bacteriology

    The last bacteriological exams will be noted

    Time frame: 14 days

  5. Nutrition assessment

    Body mass index

    Time frame: 14 days

06

Study locations

1 of 1 sites recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Recruiting
07

Registry details

Key details

Study ID
NCT03273959
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
Aug 28, 2017
Primary completion
Aug 28, 2018 (estimated)
Completion
Mar 28, 2019 (estimated)
Last update
Sep 6, 2017

Study contacts

Bruna Ziegler
Contact
brunaziegler@yahoo.com.br
5551991221192
Taiane Feiten
Contact
taifeiten@gmail.com
5551991539788
Bruna Ziegler
study director · Hospital de Clínicas de Porto Alegre

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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